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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00357318 |
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sunitinib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with sunitinib may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bevacizumab and sunitinib in treating patients with solid tumors.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: bevacizumab Drug: sunitinib malate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Bevacizumab in Combination With SU11248 |
Estimated Enrollment: | 24 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and oral sunitinib malate (SU11248) once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of bevacizumab and SU11248 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 10 patients are treated at the MTD.
After completion of study therapy, patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Urine protein:creatinine ratio ≤ 0.5 by urinalysis
None of the following within the past 12 months:
No hypertension that cannot be controlled by medications
PRIOR CONCURRENT THERAPY:
No prior bevacizumab or sunitinib malate (SU11248)
No concurrent full-dose anticoagulants (e.g., warfarin)
United States, Ohio | |
Case Comprehensive Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44106-5065 | |
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 | |
Cleveland Clinic Taussig Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |
Geauga Regional Hospital | Recruiting |
Cleveland, Ohio, United States, 44024 | |
Contact: Matthew M Cooney 216-691-0100 | |
Lake/University Ireland Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44060 | |
Contact: Matthew M Cooney 216-691-0100 | |
University Suburban Health Center | Recruiting |
Cleveland, Ohio, United States, 44121 | |
Contact: Matthew M Cooney 216-691-0100 | |
Southwest General Health Center | Recruiting |
Cleveland, Ohio, United States, 44130 | |
Contact: Matthew M Cooney 216-691-0100 | |
UHHS Chagrin Highlands Medical Center | Recruiting |
Cleveland, Ohio, United States, 44122 | |
Contact: Matthew M Cooney 216-691-0100 | |
UHHS Westlake Medical Center | Recruiting |
Cleveland, Ohio, United States, 44145 | |
Contact: Matthew M Cooney 216-691-0100 | |
Mercy Cancer Center at Mercy Medical Center | Recruiting |
Cleveland, Ohio, United States, 44708 | |
Contact: Matthew M Cooney 216-691-0100 |
Study Chair: | Brian I. Rini, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000489184, CASE-5Y05, CASE-5Y05-CC008, NCI-7537 |
Study First Received: | July 26, 2006 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00357318 |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific |
Sunitinib Bevacizumab |
Antineoplastic Agents Therapeutic Uses Growth Substances Physiological Effects of Drugs |
Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |